Examining Whether Project Support Works

Randomized Controlled Trial of Project Support

This study will involve a randomized, controlled trial with two parallel groups, Project Support and a treatment as usual control group. Families with a child on the waitlist for trauma-focused services will be invited to participate. Participation involves completing a baseline assessment of family functioning and trauma characteristics. Participants will then be randomized to either Project Support or the treatment as usual control group. All participants will be invited to complete the post-test assessment 4-6 weeks after the baseline assessment, prior to beginning trauma-focused services.

Study Overview

• Status: Recruiting
• Conditions: Parent-Child Relations; Child Mental Health; Parenting Self Efficacy
• Intervention / Treatment: Behavioral: Project Support; Behavioral: Case Management Services

Detailed Description

The proposed research addresses the dearth of brief, empirically-supported programs designed for caregivers to mitigate the adverse effects of child trauma. This project will examine the telehealth delivery of Project Support, a program that addresses parenting skills and behavior problems among children exposed to violence or maltreatment. Project Support uses didactic, tailored instruction to teach caregivers how to listen to and comfort their child. This study builds on prior research which has found that Project Support is feasible and acceptable for both treatment providers and families on the waitlist for trauma-focused services. This phase of the research will examine the preliminary efficacy of Project Support in a randomized controlled trial, evaluating the impact of this intervention on caregiver emotional support, parenting self-efficacy, and family distress, compared to treatment as usual.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caitlin Rancher, PhD; Phone Number: 843-608-0491; Email: rancher@musc.edu
• Study Contact Backup: Name: Research Coordinator; Email: projectsupport@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Principal Investigator: Caitlin Rancher, PhD
      • Contact: Principal Investigator; Phone Number: 843-608-0491; Email: rancher@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Family is seeking trauma-focused services for their child;
• Child is between 6 - 13 years old;
• Caregiver agreed to be contacted for volunteer research opportunities;
• Caregiver and child can communicate in English or Spanish;
• Child has been living with caregiver for the last 6 months or longer;
• Family is able to participate in services delivered via telehealth.

Exclusion Criteria:

• Child or caregiver has a diagnosis that would impair their ability to participate in or benefit from services (e.g., traumatic brain injury, developmental disability, psychosis);
• Child is in Foster Care or Department of Social Services custody;
• The caregiver is unwilling or unable to give informed consent and/or the child is unwilling and unable to give assent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Project Support; All participants will complete a baseline assessment on demographics, parenting behaviors, and mental health symptoms. Participants randomized to the experimental condition will receive Project Support and be offered case management services. Approximately 4-6 weeks after the baseline assessment all participants will complete a post-test assessment that includes measures of service satisfaction.	Behavioral: Project Support; The Project Support intervention involves up to four 60-minute individual counseling sessions focused on teaching caregivers how to listen to and comfort their child. Participants will receive didactic instruction and feedback on their use of the skills in role-plays with a treatment provider and with their child. In the role-plays the provider first demonstrates how to use the skill in a brief example of typical situations in which the skill could be used. In these examples the caregiver takes on the role of their child and the provider takes on the role of the caregiver. Subsequently the caregiver and provider switch roles so the caregiver has an opportunity to practice executing the skill. The provider helps the caregiver process their experience of each role-play and provides real-time, targeted feedback to help the caregiver develop their ability to use the skills.; Behavioral: Case Management Services; Case management services, or treatment as usual, may involve referrals for financial resources or donated goods, as well as assistance with court, law enforcement, or information about orders of protection. The nature of these services depends on the needs identified by the family and case manager. There is currently no standard "treatment" offered to families on the waitlist. This condition will receive individually tailored services, as needed.
Other: Treatment as usual; All participants will complete a baseline assessment on demographics, parenting behaviors, and mental health symptoms. Participants randomized to the treatment as usual condition will receive routine provision of case management services. Approximately 4-6 weeks after the baseline assessment all participants will complete a post-test assessment that includes measures of service satisfaction.	Behavioral: Case Management Services; Case management services, or treatment as usual, may involve referrals for financial resources or donated goods, as well as assistance with court, law enforcement, or information about orders of protection. The nature of these services depends on the needs identified by the family and case manager. There is currently no standard "treatment" offered to families on the waitlist. This condition will receive individually tailored services, as needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parenting self-efficacy assessed by the Tool to Measure Parenting Self-Efficacy (TOPSE)	Caregivers will complete the Tool to Measure Parenting Self-Efficacy (TOPSE). Responses to this questionnaire assess several domains of parenting. Responses to items assessing parenting self-efficacy (e.g., "I am able to comfort my child") are made on a 11-point scale (0 = completely disagree, 10 = completely agree). Responses are summed to create a total score. This outcome measure will be assessed by comparing both within- and between-person changes in parenting self-efficacy from baseline to post-test.	Baseline to Post-test (6 weeks)
Supportive parenting assessed by the Parent Behavior Inventory	Caregivers and children will complete convergent versions of the Parent Behavior Inventory. Responses to this questionnaire assess several domains of parenting. Responses to items assessing supportive/engaged parenting (e.g., "I listen to ___'s feelings and try to understand them") are made on a 6-point scale (0 = not at all true to 5 = very true). Responses are summed to create a total score. This outcome measure will be assessed by comparing within- and between-person changes in supportive parenting from baseline to post-test.	Baseline to Post-test (6 weeks)
Attendance to trauma-focused treatment intake session coded from clinical records	Research staff will review clinical records to determine whether participants attended their intake session. This will be coded dichotomously as whether or not the family attends the intake appointment ( 0 = did not attend intake, 1 = attended intake). Families will be determined to have attended their intake if this is noted either in clinic records as "in treatment" or if there is an "intake note" available in the clinical record. We will monitor the status of intake attendance for up to 4 months after the family completes participation in the post-test assessment.	4 months after Post-test

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child psychological distress assessed by the Pediatric Symptom Checklist	Caregivers and children will complete convergent versions of the Pediatric Symptom Checklist. Responses to items on this questionnaire measuring child psychological distress (e.g., "Feels sad, unhappy") are made on a 3-point scale (0 = never, 1 = sometimes, 2 = often). Responses are summed to create a total score, with higher scores indicating greater psychological distress. This outcome measure will be assessed by comparing within and between-person changes in child psychological distress from baseline to post-test.	Baseline to Post-test (6 weeks)
Child self-blame appraisals assessed by the Child Attributions and Perceptions Scale (CAPS)	Children will complete the Child Attributions and Perceptions Scale (CAPS) assessing their self-blame appraisals (e.g., "Do you blame yourself when things go wrong?") on a 5-point scale (1 = never to 5 = always). Responses are summed to create a total score, with higher scores indicating greater self-blame. This outcome measure will be assessed by comparing within- and between-person change from baseline to post-test.	Baseline to Post-test (6 weeks)

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Caitlin Rancher, PhD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: April 25, 2025
• First Submitted That Met QC Criteria: May 6, 2025
• First Posted (Actual): May 9, 2025

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Non-offending caregiver; Child trauma
• Other Study ID Numbers: Pro00144297

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No